Latest news with #PDL1
Medscape
10 hours ago
- Health
- Medscape
ASCO 2025: New Standards Reshape Care in mBC
Heather McArthur, MD, describes how the 2025 ASCO Annual Meeting brought exciting advances in the metastatic breast cancer space. In PD-L1-positive triple-negative breast cancer, sacituzumab govitecan combined with pembrolizumab significantly improved progression-free survival over standard chemotherapy plus pembrolizumab, quickly becoming a new standard of care. Similarly, in HER2-positive disease, trastuzumab deruxtecan combined with pertuzumab outperformed traditional THP therapy, offering a new frontline option. Overall, these findings signify a major shift in how to treat metastatic breast cancer.
Medscape
11-06-2025
- Health
- Medscape
Can a TKI Boost Anti-PD-L1 Activity in NSCLC?
Can adding a TKI that targets programmed death ligand 1 (PD-L1) to a monoclonal antibody that also targets PD-L1 improve outcomes over the monoclonal antibody alone in locally advanced, unresectable non-small cell lung cancer (NSCLC)? Researchers in China have come in with a qualified yes. The authors of the new study found that a combination of anlotinib, an oral small-molecule TKI, and benmelstobart (TQB2450), a humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody that targets PD-L1, improved progression-free survival (PFS) compared with benmelstobart alone after concurrent/sequential chemoradiotherapy (60 Gray ± 10%). A downside of taking the TKI was a significant increase in side effects, Ming Chen, MD, PhD, lead investigator of the R-ALPS trial, reported at American Society of Clinical Oncology (ASCO) 2025. Study Results 'Our key finding demonstrated significant improvement in median PFS with the combination of benmelstobart plus anlotinib, with a median PFS of 15.1 months compared to 9.7 months with benmelstobart alone and 4.2 months with placebo,' said Chen, while presenting the abstract at the meeting. PFS was the primary endpoint of the study. Ming Chen, MD, PhD 'This translated into a reduced risk of disease progression with a hazard ratio of 0.49 for the combination arm and 0.53 for benmelstobart alone,' vs placebo, said Chen, who is director of Radiation Oncology at the Sun Yat-sen University Cancer Center in Guangzhou, China. The P values for both were less than .0001. Chen reported results of an interim analysis of the phase 3 R-ALPS study, which randomized 553 patients to one of three treatment groups after all received concurrent/sequential chemoradiotherapy: Benmelstobart alone, benmelstobart plus anlotinib, or placebo. Twelve-month PFS rates were 54.9% in the combination group, 45.7% in the benmelstobart alone group, and 26.4% in the placebo group. The data analysis of overall survival rates has not been completed, Chen said. Among secondary endpoints, overall response rates were 25.6% ( P = .01), 23.3 ( P = .0318), and 12.9% for the combination, benmelstobart alone, and placebo groups, respectively. The disease control rates were 84.5% ( P = .0067) and 86.1% ( P = .0023) for the combination and benmelstobart alone groups, respectively, and was 70.5% for the placebo group. Safety Profile 'Manageable' or 'Significant'? The combination group had consistently higher rates of adverse events than the other two groups. Chen said the safety profile of adding anlotinib to benmelstobart was 'manageable,' while Shankar Siva, PhD, MBBS, a discussant at the oral abstracts session, characterized the toxicity profile of the study as 'significant.' Shankar Siva, PhD, MBBS Overall, the rates of grade 3-5 treatment-related adverse events (TRAEs) were 50% in the combination group, 32% in the benmelstobart alone group, and 21% in the placebo group. The rates of serious TRAEs were 38.3%, 33% and 26.5%, respectively. Hematologic toxicities were not significantly different across the three groups, Chen said, but the following four biochemical measures were significantly elevated in the combination group: Antistreptokinase, creatine phosphokinase, thyroid-stimulating hormone, and amylase. Among the grade 3-5 non-hematologic TRAEs, rates of infectious pneumonia, hypertension, and hemoptysis were significantly higher in the combination group: 8.1%, 8.6%, and 2.4%, respectively, vs 4.7%, 0.9%, and 0.5% in the benmelstobart alone group and 5.3%, 1.8%, and 0.8% in the placebo group. Chen added that the rates of radiation pneumonitis and immune pneumonitis 'were very mild in all three arms,' with rates below 3%. Elaborating on his different take on the combination treatment's safety profile from Chen's, Siva said the incidence of high-grade adverse events in this study was notable. 'More targeted or bispecific TKIs' might be worth exploring in a combination treatment after chemoradiotherapy for NSCLC to improve the safety profile, he said, during the session. Knowing biomarkers of benefit and potential toxicity would also be important for using multitarget TKIs in combination therapies after chemoradiotherapy for NSCLS, noted Siva, who is a radiation oncologist at Peter MacCallum Cancer Centre in Melbourne, Australia. One of the limitations of the study was that all patients were Chinese, Chen said. Anlotinib was approved for advanced NSCLC in China in 2019. Chia Tai TianQing Pharmaceutical Group funded the study. Chen reported having no relevant financial relationships. Siva reported having financial relationships with AstraZeneca, Bayer, Bristol Myers Squibb, Merck Sharp & Dohme, and Varian Medical Systems.
Associated Press
30-05-2025
- Business
- Associated Press
Clinical Trials Demonstrate Monitoring PD-L1 Upregulation Using LifeTracDx Blood Test Could Support New Treatment Path for Metastatic Triple Negative Breast Cancer
MONMOUTH JUNCTION, N.J., May 30, 2025 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. ('Creatv') in collaboration with CytoDyn Inc. ('CytoDyn') presents promising four-year survival rates from a pooled clinical trial analysis of patients with metastatic triple-negative breast cancer ('mTNBC') treated with leronlimab and PD-L1 immune checkpoint inhibitors ('ICI'). Leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, was tested with and without ICIs in n=28 mTNBC patients. Results indicated that leronlimab treatment correlated with increased expression of PD-L1 on circulating tumor associated cells, as measured using the LifeTracDx® blood test from Creatv. The analysis also revealed promising survival observations among patients who experienced a significant increase in PD-L1 expression and subsequently pursued treatment with an ICI. Four year follow-up results were presented at the ESMO Breast Cancer meeting on May 15, 2025 by Dr. Richard Pestell, available here. The LifeTracDx® is a universal cancer blood test that uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response in cancer patients. In the trials presented at ESMO, results showed that monitoring the expressions of PD-L1 before and after induction of leronlimab using the LifeTracDx® blood test identified upregulation of PD-L1 expression in 76% of patients after therapy induction. In a 4-year overall survival follow-up, 5 of the patients with upregulated PD-L1 detected by LifeTracDx® blood test and treated with the ICIs atezolizumab or pembrolizumab were alive after four years. About Creatv Bio Creatv Bio is a cancer screening and cancer diagnostics company providing testing services to patients and to pharma companies to support drug development from its laboratory in NJ. Creatv's scientists were the first to publish on CAMLs found in the blood of cancer patients. LifeTracDx® blood tests have an array of clinical applications including predicting response to a new therapy in 30 days, providing companion/complementary diagnostics such as PD-L1 using blood samples, providing information about aggressiveness of the cancer, detection of minimal residual disease, early detection of cancer recurrence, and cancer screening. For a complete listing of our journal publications and posters, please visit our website. Creatv contacts: View original content to download multimedia: SOURCE Creatv MicroTech, Inc.
Globe and Mail
30-05-2025
- Business
- Globe and Mail
ImmunoGenesis to present IMGS-001 Phase 1a/1b Clinical Study Updates at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
IMGS-001 is first dual-specific PD-L1/PD-L2 antibody with cytotoxic killing function and is designed to treat the many "immune-excluded" cancers that are resistant to existing immunotherapies HOUSTON , May 30, 2025 /CNW/ -- ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, announced today that a Trial in Progress poster for its first-in-human, Phase 1a/ 1b clinical trial of IMGS-001 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois from May 30 to June 3, 2025 . This Phase 1a/ 1b first-in-human, open-label, multicenter study (NCT06014502) includes a dose escalation and an expansion portion to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment. The study will enroll approximately 25 patients in Phase 1a and up to 250 in Phase 1b . The first three of five planned dose cohorts have completed without any dose limiting toxicities (DLTs), with cohort 4 (10 mg/kg) now enrolling. "This clinical trial is an important first step to understand how IMGS-001 may potentially remove immunosuppressive cells while improving PD-1 pathway blockade to treat otherwise immunoresistant tumors that represent a significant unmet medical need," stated Charles Schweizer , PhD, Senior Vice President of Clinical Development at ImmunoGenesis. "We are pleased to discuss the study plan and progress at this important conference as we look ahead to sharing results." "We are encouraged by the early performance of IMGS-001 as we proceed with Phase 1 dose escalation in patients with a variety of advanced solid tumors," said James Barlow , President and CEO of ImmunoGenesis. "Initial low doses administered to date have been well-tolerated with no dose-limiting toxicities, and we are seeing promising early signs of anti-tumor activity in patients who have failed prior treatments. IMGS-001 has the potential to be a foundational therapy for immune-excluded tumors, addressing a major unmet need." ASCO Poster Presentation Title: A Phase 1a/ 1b study to evaluate the safety, tolerability, Pharmakokinetics, and anti-tumor activity of IMGS-001 in Patients with relapsed or refractory advanced solid tumors. Abstract: TS2686 | Poster Bd #: 324a Track: Developmental Therapeutics—Immunotherapy Location: Hall A -Posters and Exhibits | On Demand Time: June 2, 2025 , 1:30 PM – 4:30 PM CDT About ImmunoGenesis ImmunoGenesis is a clinical-stage biotech company dedicated to transforming immuno-oncology by targeting key mechanisms of immune resistance. The company's lead product, IMGS-001, is a cytotoxic, dual-specific PD-L1/PD-L2 antibody currently in a Phase 1a/b clinical trial for the treatment of immune-excluded ("cold") tumors, which account for more than half of all cancers. In addition to its lead program, the company is developing a number of novel approaches to overcome immune resistance in cold tumors. ImmunoGenesis designs therapies to address the pathology of these tumors, overcoming immune exclusion to elicit a robust immune response. For more information, visit About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor IMGS-001, the lead program at ImmunoGenesis, is a PD-L1/PD-L2 dual-specific monoclonal antibody with engineered cytotoxic effector function. IMGS-001 is the first molecule in clinical testing to target PD-L2 in addition to PD-L1, potentially improving blockade of the PD-1 pathway. The engineered effector function may enable IMGS-001 to eliminate immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, providing the potential to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove higher response rates in head-to-head studies compared to currently available immunotherapies. IMGS-001 may provide a new foundational therapy with its innovative multitasking mechanism of superior blockade and cytotoxic effector function. IMGS-001 is being developed with support from the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094 as well as an investment from the Cancer Focus Fund, LP. Contact ImmunoGenesis
